Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Not Applicable

Completed

• Conditions: Corneal Astigmatism; Cataract

• Registration Number: NCT03791619
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study Start: 2018-12-13
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-02
• Primary Completion: 2022-08-08
• Study Completion: 2022-08-08
• Results First Submitted: 2023-07-07
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Results First Posted: 2023-08-29
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

• be at least 22 years old
• have cataracts in both eyes
• have a certain degree of astigmatism in at least one eye
• sign the written informed consent
• be willing and able to comply with examination procedures
• understand, read and write English to complete informed consent and questionnaires
• be available for study follow-up visits

Both eyes must qualify to be eligible to participate in the study

Exclusion Criteria

• Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
• Have a certain disease/illness such as poorly-controlled diabetes
• Have certain ocular conditions such as uncontrolled glaucoma
• Taking medication that may affect subject vision
• Have irregular corneal astigmatism
• Pregnant, plan to become pregnant during the study, or is breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Bothersome Visual Symptoms	6-month	The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Rate of Difficulty With an Activity Due to the Visual Symptoms	6-month	The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.

Trial Locations

Locations (23)

Empire Eye & Laser Center; 🇺🇸 Bakersfield, California, United States

Southern California Eye Physicians & Associates; 🇺🇸 Long Beach, California, United States

Santa Monica Eye Medical Group; 🇺🇸 Santa Monica, California, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Florida Eye Microsurgical Institute, Inc.; 🇺🇸 Boynton Beach, Florida, United States

The Eye Associates of Manatee; 🇺🇸 Bradenton, Florida, United States

Levenson Eye Associates; 🇺🇸 Jacksonville, Florida, United States

North Florida Eye Surgeons, LLC dba Florida Eye Specialist; 🇺🇸 Jacksonville, Florida, United States

Center For Sight; 🇺🇸 Sarasota, Florida, United States

Virdi Eye Clinic & Laser Vision Care; 🇺🇸 Rock Island, Illinois, United States

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